BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE— 510(k) K053443

Name: FDA 510(k) clearance K053443
Creator: U.S. Food and Drug Administration
Published: 2006-02-01

Substantially Equivalent

Regent Medical Americas, LLC

FDA 510(k) clearance K053443 for BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE, Substantially Equivalent on 2006-02-01. Applicant: Regent Medical Americas, LLC. Device class: 1.

Clearance details

Applicant: Regent Medical Americas, LLC
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2005-12-09
Decision date: 2006-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.